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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007280 ()


  • Radiological PACS software
InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI.
ANATOMAGE, INC.
1.0
In Commercial Distribution

  • 00852060007105 ()


  • Radiology information system application software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution

  • 00850018992619 ()


  • Self-care monitoring/reporting software
Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.
NCS LAB SRL
SHWM01SW1
In Commercial Distribution

  • 08051122041091 ()


  • Biomechanical function analysis/rehabilitation software
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Inc.
RMD-WEB-I
Not in Commercial Distribution

  • B037RESMDWEB0 ()


  • Radiological PACS software
No Description
Biomet Orthopedics, LLC
1312-20-255
In Commercial Distribution

  • 00887868013386 ()

  • 2.5 mm
131220255

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
1312-20-155
In Commercial Distribution

  • 00887868013317 ()

  • 1.5 mm
131220155

  • Orthopaedic fixation plate, non-bioabsorbable
SCOPE TO OPEN
Cardinal Health 200, LLC
SOP33SCPI1
In Commercial Distribution

  • 50195594073013 ()
  • 10195594073015 ()
SOP33SCPI1

  • Arthroscopic surgical procedure kit, non-medicated, single-use
Male to Male
DEROYAL INDUSTRIES, INC.
77-400259
In Commercial Distribution

  • 50749756289943 ()
  • 00749756289948 ()


  • Basic intravenous administration set, noninvasive
SCOPE TO OPEN
Cardinal Health 200, LLC
SOP33SAPS2
In Commercial Distribution

  • 50195594324146 ()
  • 10195594324148 ()
SOP33SAPS2

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SCOPE TO OPEN
Cardinal Health 200, LLC
SOP33SCPI2
In Commercial Distribution

  • 50195594272836 ()
  • 10195594272838 ()
SOP33SCPI2

  • Arthroscopic surgical procedure kit, non-medicated, single-use
Connection to handpiece
Cochlear Bone Anchored Solutions AB
90478
In Commercial Distribution

  • 09321502020732 ()
90478

  • General external orthopaedic fixation system implantation kit, reusable
Flex TO Drive
MEDROBOTICS CORPORATION
24324
In Commercial Distribution

  • 00850190004049 ()


  • Flexible video otorhinolaryngoscope, reusable
curved to side
Spiggle & Theis Medizintechnik GmbH
20-115-00
In Commercial Distribution

  • 04250381823316 ()
20-115-00

  • Nasal speculum, reusable
SCOPE TO OPEN
Cardinal Health 200, LLC
SOP33SCPIA
In Commercial Distribution

  • 50887488449683 ()
  • 10887488449685 ()
SOP33SCPIA

  • Arthroscopic surgical procedure kit, non-medicated, single-use
Connector to scope
PENTAX OF AMERICA, INC.
8873
Not in Commercial Distribution

  • 04961333230266 ()


  • Rigid optical nasopharyngoscope
Connector to scope
PENTAX OF AMERICA, INC.
8872
In Commercial Distribution

  • 04961333230259 ()


  • Rigid optical nasopharyngoscope
Connector to scope
PENTAX OF AMERICA, INC.
8871
In Commercial Distribution

  • 04961333230242 ()


  • Rigid optical nasopharyngoscope
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-76-1550
In Commercial Distribution

  • 10705034596099 ()
5560761550

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6.35mm
DEPUY SPINE, LLC
5560-72-2152S
In Commercial Distribution

  • 10705034588001 ()
5560722152S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-72-4152S
In Commercial Distribution

  • 10705034587998 ()
5560724152S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-2551S
In Commercial Distribution

  • 10705034587974 ()
5560782551S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-1552S
In Commercial Distribution

  • 10705034587967 ()
5560781552S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-1551S
In Commercial Distribution

  • 10705034587950 ()
5560781551S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-1553S
In Commercial Distribution

  • 10705034587943 ()
5560781553S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-76-2550S
In Commercial Distribution

  • 10705034587257 ()
5560762550S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-76-1550S
In Commercial Distribution

  • 10705034587240 ()
5560761550S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-2553S
In Commercial Distribution

  • 10705034584171 ()
5560782553S

  • Bone-screw internal spinal fixation system connector
ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560-78-2552S
In Commercial Distribution

  • 10705034584164 ()
5560782552S

  • Bone-screw internal spinal fixation system connector
Mitten to Elbow
Gottfried Medical, Inc.
452
In Commercial Distribution

  • G420452 ()
452

  • Compression/pressure glove
Mitten to Wrist
Gottfried Medical, Inc.
451
In Commercial Distribution

  • G420451 ()
451

  • Compression/pressure glove
Gauntlet to Elbow
Gottfried Medical, Inc.
404
In Commercial Distribution

  • G420404 ()
404

  • Compression/pressure glove
Glove to Elbow
Gottfried Medical, Inc.
402
In Commercial Distribution

  • G420402 ()
402

  • Compression/pressure glove
Glove to Wrist
Gottfried Medical, Inc.
401
In Commercial Distribution

  • G420401 ()
401

  • Compression/pressure glove
Glove to Axilla
Gottfried Medical, Inc.
400
In Commercial Distribution

  • G420400 ()
400

  • Compression/pressure glove
Gauntlet to Axilla
Gottfried Medical, Inc.
102
In Commercial Distribution

  • G420102 ()
102

  • Compression/pressure sock/stocking, reusable
TO BE OBSOLETED
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
280225
Not in Commercial Distribution

  • M2742802251 ()
  • 10381780176954 ()
280-225

  • Spinal rongeur
WILLIAMSBURG TO KIT
MEDLINE INDUSTRIES, INC.
DYKC1990
In Commercial Distribution

  • 40198459234980 ()
  • 10198459234989 ()
DYKC1990

  • General surgical procedure kit, non-medicated, single-use
Connection to Handpiece
Nobel Biocare AB
29081
In Commercial Distribution

  • 07332747208290 ()
29081

  • Surgical screwdriver, reusable
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